Kenvue is currently recruiting for a:
Quality Systems Lead
What we do
At Kenvue , we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.
Who We Are
Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information , click here .
Role reports to:
Senior Manager, Quality Systems
Location:
North America, United States, New Jersey, Summit
Work Location:
Hybrid
What you will do
The Quality Systems Lead’s primary focus will be regulatory standards management, supporting the monitoring, assessment and implementation of new or revised GxP regulations and standards across North America. The Quality Systems Lead translates regulatory requirements into practical business actions, coordinates cross-functional impact assessments, monitors implementation workstreams, and identifies and escalates key risks and concerns to support effective oversight and decision making. The role works with regional and global stakeholders to support timely compliance, communicate regulatory changes and escalate risks.
The role will also support other areas of quality systems and compliance based on business needs and priorities, which may include quality system process improvements such as change control, investigations and corrective and preventive actions (CAPA), governance reporting, and audit and inspection readiness. These responsibilities will involve cross-functional collaboration to strengthen process consistency, maintain effective compliance oversight and support continuous improvement across North America.
Key Responsibilities
Monitor new and revised approved regulations and standards within the assigned geographic and functional scope. Communicate relevant changes promptly to allow assessment and implementation before regulatory effective dates. Monitor draft regulations when assigned to support readiness for potential changes.
Determine regulatory applicability by product category, business function, process and market. Review existing/new RTC records and support coordination across regions.
Core competency around:
Apply working knowledge of product formulations, including the functions of active and inactive ingredients, raw material attributes and finished-product specifications, to support regulatory applicability and product impact assessments.
Demonstrate an understanding of formulation-related quality considerations, including ingredient compatibility, stability, physicochemical properties, microbiological quality and packaging compatibility, and collaborate with technical subject matter experts to assess potential compliance implications.
Partner with Research and Development, Regulatory Affairs, Manufacturing and Quality teams to assess changes to formulations, raw materials or specifications through applicable change control processes, supporting documented evaluation of product quality, testing, validation and regulatory impacts.
Coordinate documented impact and gap assessments with subject matter experts. Evaluate implications for products, quality systems, operating procedures, training, resources and regulatory filings, as applicable.
Track implementation through completion via applicable quality system processes, including change control, document revisions, training, and investigations or corrective and…